(83 days)
Not Found
No
The description focuses on the device's function as a communication gateway and web server for image and report distribution, with no mention of AI or ML capabilities.
No
The device is described as a medical communication device (gateway device) for image and report distribution, and data transfer, explicitly stating that images are not for primary diagnosis. It functions as an accessory to hospital information systems, rather than directly treating or diagnosing patients.
No
Explanation: The "Intended Use" section explicitly states that "Images distributed by the MagicWeb are for viewing purposes and are not intended for primary diagnosis." This indicates it's a communication and distribution device, not for diagnostic interpretation.
Yes
The device description explicitly states that the products are "medical communication devices (gateway devices)" and describes their function as a web server and a gateway connection for transferring information. There is no mention of any hardware components being part of the device itself, only that it interacts with existing systems (SIENET, RIS/HIS) and uses commercially available web browsers.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the SIENET MagicWeb and MagicLink I are "medical communication devices (gateway devices)." Their purpose is to facilitate the transfer and viewing of medical images and data between different hospital systems (SIENET, RIS/HIS).
- No Biological Samples: There is no mention of the device interacting with or analyzing biological samples from patients.
- Focus on Data Transfer and Viewing: The primary functions described are image and report distribution for viewing purposes (not primary diagnosis) and the transfer of patient demographic and examination data.
Therefore, the device's function falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SIENET MagicWeb and MagicLink I are medical communication devices (gateway devices). The MagicWeb is a web server intended to provide lowend image and report distribution. Images and reports can be viewed by accessing the server using commercially available Web Browsers. Images distributed by the MagicWeb are for viewing purposes and are not intended for primary diagnosis.
The MagicLink I is a gateway connection between SIENET and RIS/HIS systems. Patient demographic information and examination data (text only) are transferred across the gateway. This device is an accessory to hospital information systems.
Product codes (comma separated list FDA assigned to the subject device)
90 LMD
Device Description
This premarket notification covers the SIENET gateway product line, specifically, SIENET MagicLink I (ISI-Gateway) and MagicWeb (web server).
The SIENET MagicWeb and MagicLink I are medical communication devices (gateway devices). The MagicWeb is a web server intended to provide low-end image and report distribution. Images and reports can be viewed by accessing the server using commercially available Web Browsers. Images distributed by the MagicWeb are for viewing purposes and are not intended for primary diagnosis.
The MagicLink I is a gateway connection between SIENET and RIS/HIS systems. Patient demographic information and examination data (text only) are transferred across the gateway. This device is an accessory to hospital information systems.
These products support industry standard information transmission and communication protocols.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
SIEMENS
K973131 Attachment K: 510(k) Summary
510(k) Summary
NOV 1 2 1997
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
- GENERAL INFORMATION I.
Establishment:
| • Address: | Siemens Medical Systems, Inc.
186 Wood Avenue South
Iselin, NJ 08830 |
| ------------ | ---------------------------------------------------------------------------- |
|---|
- 2240869 . Registration Number:
Kathleen Rutherford Contact Person: ● Manager, Regulatory Submissions (908)321-4779, Telefax: (908)321-4841 after December 1, 1997: (732) 321-4779, Telefax: (732) 321-4841
Device Name:
- SIENET Gateway product line: ● Trade Name: MagicWeb and MagicLink I
- On November 17, 1996, FDA proposed classi-Classification: . fications for five Medical Image Management Devices. One classification was defined as Medical Image Communications Device (Sec. 892.2020). This type of device was defined as Class I exempt from premarket notifications requirements only when the devices transfers images without performing irreversible or lossy compression. The SIENET gateway products that are described in this premarket notification fall within the definition of a Medical Image Communications Devices (as defined by FDA in its classification proposal.
- Performance Standards: None established under Section 514 of the Food, ● Drug, and Cosmetic Act
1
SIEMENS
II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
Device Description and Intended Use: .
This premarket notification covers the SIENET gateway product line, specifically, SIENET MagicLink I (ISI-Gateway) and MagicWeb (web server).
The SIENET MagicWeb and MagicLink I are medical communication devices (gateway devices). The MagicWeb is a web server intended to provide low-end image and report distribution. Images and reports can be viewed by accessing the server using commercially available Web Browsers. Images distributed by the MagicWeb are for viewing purposes and are not intended for primary diagnosis.
The MagicLink I is a gateway connection between SIENET and RIS/HIS systems. Patient demographic information and examination data (text only) are transferred across the gateway. This device is an accessory to hospital information systems.
These products support industry standard information transmission and communication protocols.
Technological Characteristics: ●
The MagicWeb described supports DICOM 3.0, GIF, and JPEG. The MagicLink I supports DICOM 3.0 and HL7 via an OEM interface.
. General Safety and Effectiveness Concerns:
The device labeling contains instructions for use. It includes indications for use and any cautions. This information provides for safe and effective use of the device.
. Substantial Equivalence:
The SIENET gateway products, addressed in this premarket notification, are substantially equivalent to the following commercially available devices:
- Siemens: SIENET SPI Import/Export Spooler [K953522]
- . Mitra Imaging: HIS-SCP (Mitra Broker)
- PixeLinks: FreePix/PixPACS [K970174]
- Autocytgroup: Amicas Web Intranet Image Server [K970064] .
The SIENET gateway products described in this 510(k) have the same intended use and similar technical characteristics as the devices listed above.
Kathleen Rutherford
Signature
8/20/92
Date
510(k) Premarket Notification
2
Image /page/2/Picture/17 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 1997
Amy Shaw Hosler Senior Technical Specialist Siemens Medical Systems 186 Wood Avenue South Iselin, NJ 08830
Re: K973131
Sienet Magic Web and MagicLink I Dated: August 19, 1997 Received: August 21, 1997 Regulatory class: Unclassified Procode: 90 LMD
Dear Ms. Hosler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
W.Liliau Yu
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
CONFIDENTA
510(k) Number (if known): Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The SIENET MagicWeb and MagicLink I are medical communication devices (gateway devices). The MagicWeb is a web server intended to provide lowend image and report distribution. Images and reports can be viewed by accessing the server using commercially available Web Browsers. Images distributed by the MagicWeb are for viewing purposes and are not intended for primary diagnosis.
The MagicLink I is a gateway connection between SIENET and RIS/HIS systems. Patient demographic information and examination data (text only) are transferred across the gateway. This device is an accessory to hospital information systems.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Lórid C. de yorm
(Division Sign off)
(Division Sign-off) Division of Reproductive Abdominal, ENT, and Radiological Devices
510(k) Number K973131
Prescription Use OR Over-the-counter Use